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FDA 510(k)

FPR PHENYTOIN KIT

K-Number: K894527 · 1989-09-25

ApplicantColony Laboratories, Inc.
Decision Date1989-09-25
Product CodeDLP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FPR PHENYTOIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Colony Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-25 under 510(k) number K894527. The device is classified under product code DLP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FPR PHENYTOIN KIT?

FPR PHENYTOIN KIT is a medical device that received FDA 510(k) clearance on 1989-09-25. The listed applicant is Colony Laboratories, Inc.. The 510(k) number is K894527.

When did FPR PHENYTOIN KIT receive FDA 510(k) clearance?

FPR PHENYTOIN KIT received FDA 510(k) clearance on 1989-09-25, under 510(k) number K894527.

Who is the listed applicant for FPR PHENYTOIN KIT?

The FDA 510(k) record lists Colony Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FPR PHENYTOIN KIT?

The FDA product code for FPR PHENYTOIN KIT is DLP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Colony Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K894524FPR GENTAMICIN CALIBRATOR KITK894517FPR AMIKACIN KITK894523FPR GENTAMICIN KITK894518FPR AMIKACIN CALIBRATOR KITK894528FPR PHENYTOIN CALIBRATOR KITK894521FPR DIGOXIN KIT

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Related Devices (Code: DLP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K811775KALLESTAD ANTISERA TO PHENYTOINKallestad Laboratories, Inc.K792640FLUOROMATIC PHENYTOIN FIABio-RadK791896CENTRIA PHENYTOIN RIA TEST SETVentrex Laboratories, Inc.K770779PHENYTOIN RIA KITAmersham Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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